Effectiveness of Accelerated Transcranial Magnetic Stimulation in Obsessive Compulsive
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dimensional obsessive compulsive symptom severity
研究概览
简要总结
H-coil high-frequency deep transcranial magnetic stimulation (dTMS) over the medial prefrontal cortex (mPFC) and anterior cingulate cortex (ACC) has been approved by the Food and Drug Administration for use in treatment-resistant obsessive-compulsive disorder. At the same time, there are studies in the literature showing the effectiveness of intermittent theta burst stimulation application and the advantages of short treatment duration. However, there is no strong scientific evidence yet on the effectiveness and safety of iTBS (50 Hz) application with a double-cone coil in obsessive-compulsive disorder patients. The aim of this study is to evaluate the effectiveness of dTMS with ITBS protocol on the medial prefrontal cortex (mPFC) and anterior cingulate cortex (ACC) in OCD patients.
详细描述
The current study aimed to investigate the effectiveness and safety of the ITBS protocol, which is applied to the mPFC and ACC for 5 sessions per day with a double-cone coil in treatment-resistant OCD patients. This study evaluated (I) the effectiveness of Itbs (50 Hz) stimulation of the mPFC and ACC with a double-cone coil and (II) the effectiveness of administering this protocol over 2 weeks rather than six weeks as approved by the FDA. Participants will be randomized into two parallel groups in a double-blind manner. In one group, ITBS (50 Hz) dTMS will be applied to mPFC and ACC, and in the other group, sham tms will be applied to the same regions. The application consists of a total of 50 sessions, 5 times a day. This application will last for a total of 10 days excluding weekends.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of obsessive-compulsive disorder
- •Not having an adequate response to treatment despite the use of an SGI selective serotonin reuptake inhibitors at a sufficient dose and duration (at least 8 weeks) before the planned add-on treatment
- •No dose or active substance changes have been made in the treatment regimen for at least 8 weeks
- •Aged 18-65 years
- •Able to read and write
- •Not having a significant medical or neurological disease
排除标准
- •Not providing consent to participate in the study
- •Diagnosis of a psychiatric disorder, such as psychotic disorder, bipolar disorder, major depressive disorder [Hamilton Depression Rating Scale (HDRS) score above 17], mental retardation, alcohol-substance use disorder, and organic mental disorder (dementia, delirium, and head trauma, etc.)
- •Diagnosis of an important medical or neurological disease (e.g., epilepsy);
- •Mental retardation
- •Illiteracy
- •Having received electroconvulsive therapy (ECT) or TMS within the last six months;
- •Having any prosthesis, such as an implant and pacemaker.
研究组 & 干预措施
active accelerated deep TMS
Accelerated dTMS on anterior cingulate cortex and medial prefrontal cortex.
干预措施: Accelerated deep iTBS (Device)
sham TMS
Sham TMS on anterior cingulate cortex and medial prefrontal cortex
干预措施: Accelerated Sham iTBS (Device)
结局指标
主要结局
Dimensional obsessive compulsive symptom severity
时间窗: pretreatment (0.days) - as soon as the work is completed (10. days) - In the 2nd week after TMS application is completed (24. days)
Dimensional Obsessive-Compulsive Scale (DOCS). The minimum and maximum values are 0-80, and higher scores mean a worse outcome.
Obsessive compulsive symptoms severity
时间窗: pretreatment (0.days) - as soon as the work is completed (10. days) - In the 2nd week after TMS application is completed (24. days)
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). The minimum and maximum values are 0-40, and higher scores mean a worse outcome.
次要结局
- Severity of Depression(pretreatment (0.days) - as soon as the work is completed (10. days) - In the 2nd week after TMS application is completed (24. days))
- Severity of anxiety(pretreatment (0.days) - as soon as the work is completed (10. days) - In the 2nd week after TMS application is completed (24. days))
研究者
Selim Tumkaya
Professor
Pamukkale University